Appeared at the time of arguments

For the Complainants               :         Mr. D.N. Goburdhun, Advocate

 Mr. Balendu Shekhar, Advocate

 Mr. Vijayant Sharma, Advocate

 Mr. Sanyam Khetarpal, Advocate

 Mr. Nitesh Goyal, Advocate

For the Opposite Party No. 1              : Mr. Vipul Kumar Sharma, Advocate

For the Opposite Parties No.2 to 4    : Mr. K.G. Sharma, Advocate

For the Opposite Parties No.5&6       : Mr. Maibam N. Singh, Advocate

   Ms. Anjali Dhingra, Advocate

Pronounced on:  26^th August 2022

ORDER

DR. S.M. KANTIKAR, MEMBER 

Brief facts:-

1.       The present Complaint has been filed under section 21 of the Consumer Protection Act, 1986 (for short “the Act”) by the Complainants - Deepak Sahay & 2 Ors. against the Opposite Parties - Abdur Razzaque Ansari Memorial Weavers Hospitals & 5 Ors. seeking compensation for damage of Rs. 6 Crores for the act of medical negligence on the part of Opposite Parties and Rs.1 lakh towards cost of litigation/misc. expenses.

2.       Brief facts leading to the present Complaint are that Smt. Indu Sahay, the mother of the Complainants (since deceased, hereinafter referred to as the 'patient'), in her house at Ranchi, suffered a paralytic attack at around 4:00 am on 02/03/2012 and was admitted to the Opposite Party No. 1 - Hospital for emergency treatment. The patient was given tablet "Clopigrel", an alternative to 'Aspirin', as a standard treatment of stroke. Various medical tests were also conducted on the same day and they were found normal.

3.       It was alleged that the Opposite Party No. 2 and other doctors treated the patient as a guinea pig by administering two trial drugs namely "Strozagel" and "Nuravon". The treating doctors neither informed nor taken consent from anyone before administering such trial drugs. Therefore, she suffered acute myocardial infarction (heart attack) on 04/03/2012 at around 8.45 pm. Few days later, the patient suffered respiratory failure, and she was put on ventilator, but the trial drugs were continued to her. No pulmonologist was available to manage ventilator. Throughout the treatment, the Complainants were not informed about the details of the treatment. They came to know, for the first time on 25.03.2012, about trial drugs used, when they paid the pharmacy bills. As the Opposite Parties compelled the Complainants to take the patient back home, they got the patient discharged and admitted her to the nearest Om Nursing Home & Research Centre. The patient did not survive even for a day and died on next day on 26.06.2012.

4.       The Complainants alleged that the discharge summary was not issued, but it was issued with medical record on 13.04.2012 after repeated inquires. The patient’s son - Complainant No . 2, being a medical practitioner, perused the medical history and pharmacy bills which revealed about administration of aforesaid trial drugs. On enquiry through RTI application about the approval of such drug trial, the Office of Directorate General of Health Services (DGHS), in its reply dated 21.02.2013, clearly stated that those drugs have not been permitted for clinical trials for the year of 2012.  

5.       The allegation of the Complainants is that, without prior approval of licensing authority under Rule 122 DA of Drugs and Cosmetics Rules, 1945, the Opposite Parties administered trial drugs namely “STROZAGEL” and “NURAVON” to the patient. The patient was elderly, 72 years of age, having health problems like hypertension, diabetes and obesity. The treating doctor was aware of these problems and the act amounts to medical malpractice. Those drugs were still under research and experiment which have not been approved in the year 2012 for such clinical/Institutional trials/experiments on human beings. The Complainants alleged that there was breach of Regulation 7.22 of Indian Medical Council (Profession conduct, Etiquette and Ethics) Regulation, 2002 as well as the breach of ethical guidelines for Biomedical Research on Human Participants also known as the ICMR Code, 2006 and further non-observance of ‘Inclusion and exclusion criteria’. Moreover, guideline mandates to perform trial of new drugs/research only with "Informed Consent” of the patients. 

6.       Being aggrieved by the gross medical negligence on the part of Opposite Parties, the Complainants filed this Complaint and prayed for Rs. 6 Crores along with Rs. 1 lakh towards costs of litigation/misc. expenses.

Defense:

7.       The Opposite Parties filed their respective written version and denied the allegations of negligence.

8.       The Opposite Party No. 1- Hospital, in its reply, submitted that it is one of the most reputed Super Specialty Hospitals in the area and has impeachable track record. It denied negligence on the part of Opposite Party No. 1 Hospital and its staff. It was submitted that, the Complaint is barred by limitation as it was filed after 2 years from the alleged cause of action. The claim of the Complainants is imaginary to bring the complaint under the pecuniary jurisdiction of this Commission. The Hospital has insurance cover from United India Insurance Limited. The Complaint is not maintainable against the Opposite Parties as admittedly, the patient got discharged at the instance of the Complainants and thereafter, died in Om Nursing Home & Research Centre on the next day.

9.       The Opposite Parties No. 2, 3 and 4, in their reply, raised similar preliminary objections. They submitted that the alleged cause of action (of giving Inj Stroragel (Ozagrel) and Inj Edaravon (Nuravon) drugs to the patient admittedly came to the knowledge of the Complainants on 25.03.2012, when they paid the hospital bills, whereas the present Complaint was filed on 23.04.2014, with delay of 29 days. No application for condonation of delay was filed. The doctors treated the patient as per accepted standard medical protocol and no negligence or deficiency in service can be attributed to them. Hence the present Complaint deserves dismissal.

10.       It was further submitted that the patient was elderly, 72 years of age,  suffering from several health aliments like Hypertension, Diabetes Mellitus  and severe obesity. She suffered stroke before admission to the Opposite Party No. 1 - hospital. She was prone to cardiac and kidney problems due to long standing diabetes, high BP, Infection, etc. There was some recovery from renal insufficiency and the serum Creatinin was within limits after the treatment. The patient was taken off ventilator after 5 days and she was maintaining her breathing and was advised CPAP in case of difficulty. The patient attendants on their own choice took her to some sub-standard nursing home. Therefore, the treating doctors cannot be held liable for negligence.           The Complaint is not maintainable for non-joinder of proper and necessary parties as the Opposite Parties Nos. 2, 3 & 4 are duly insured with United India Insurance Company Ltd., as Professional Indemnity Insurance Policy.

11.  The Opposite Parties Nos. 5 & 6 i.e. Insurance Company, in their reply, submitted that the Insurance Company is liable to reimburse within the meaning and scope of the policy to the Opposite Parties Nos. 2 to 4, if they  are held liable for medical negligence and after their payment to the Complainants.   

Arguments:

12.     We have heard the arguments from the learned Counsel for both the sides. Perused the material on record, inter alia, the Medical Record and gave our thoughtful consideration.

13.     For the fair adjudication, we ignore the short delay of 29 days in filing the Complaint.

14.     The learned Counsel for the Complainants argued that the Opposite Parties treated the patient carelessly and committed medical negligence. He got the information through RTI application to the DGCI to inquire about the drugs in India which were administered to the patient during 02.03.2012 till 25.03.2012. He submitted that wrong drugs ‘Ozagrel’ and ‘Edaravone’ for the treatment of Acute Ischemic Stroke were prescribed during the treatment therefore the doctrine of Res ipsa Loquitur is applicable[1]. He argued that the act of Opposite parties was negligence per se[2], i.e. the conduct or the act of omission was contrary is statute. Moreover, it was the failure of duty of care from the treating doctors at the Opposite Party No. 1 - Hospital[3]. The Opposite Party No. 1 - Hospital is, therefore, vicariously liable for the act of doctors therein engaged or empaneled. The Counsel relied upon few decisions of the Hon’ble Supreme Court namely Savita Garg vs. National Heart Institute[4], Balram Prasad v. Kunal Saha[5], Achutrao Haribhau Khodwa v. State of Maharashtra[6], V. Krishnakumar v. State of Tamil Nadu[7]. He further argued that the Opposite Parties have violated basic fundamental right to life of the deceased i.e. right to adequate health care in order to survive. The Complainants' mother was a resident of USA since 1992, therefore, the Complainants deserve the compensation as prayed. For fair compensation, the Counsel relied upon the decision of Hon’ble Supreme Court in V. Krishnakumar case (supra), Maharaja Agrasen Hospital Vs Rishabh Sharma[8], Nizam Institute of Medical Sciences Vs Prasanth S Dhananka[9], Balram Prasad Vs Kunal Shah[10] etc.

15.     The learned Counsel for the Opposite Parties reiterated their evidence and the treatment aspects of the patient. He submitted that no expert opinion was filed by the Complainant to prove their allegation that the death of the patient occurred due to ‘Stroragel’ and ‘Niravon’. As per several medical literatures, the risk factors for stroke and ischemic heart disease are the same like hypertension, diabetes mellitus, smoking, obesity and dyslipidemia. Therefore, the instant patient was prone for cerebral stroke and heart attack (myocardial infarction). The Counsel submitted that at home at around 4.00 a.m. on 02.03.2012, the patient suffered paralytic stroke and was shifted as an emergency in the Opposite Party No. 1. On admission, she was given 'Clopigrel', a good alternative to 'Aspirin'. The patient suffered sudden weakness on the left side i.e. left hemiparesis. It was suspected that it was due to Transient Ischemic Attack (TIA) (without infarct) or stroke (with infarct). Therefore, it was important to prevent further extension of the thrombus. Accordingly, the patient was given IV Ozagrel (Strozagel) and also IV Edaravon (Nuravon). Only absolute contraindication of IV Ozagrel is an active bleed or risk of such a bleed, therefore, considering the old age of the patient, IV Ozagrel was given in low dose (40 mg).  At that point of time, the drugs were not trial drugs, however those drugs were available with chemist, thus already completed IV^th phase of trial.

16.     The learned Counsel for the Opposite Party No. 1 submitted that the hospital was affiliated to leading Apollo Group of hospitals and was functioning as per their standards and specifications. There was no act of any omission or commission on the part of the hospital. The alleged grievances are related to prescription of drugs, which is exclusively domain of consultant doctors – Opposite Parties Nos. 2 to 4. Therefore the hospital is not vicariously liable. The Opposite Parties Nos. 2 to 4 are duly insured by the Insurance Co. – Opposite Party No. 5.

Observations & Discussion:

17.     From the medical literature, it is known that in patients with Acute Ischemic Stroke (AIS), platelets are activated in the acute phase, releasing neurotoxic, and thrombogenic eicosanoids, which may reduce the brain blood flow and cause brain damage. Sodium ozagrel (ozagrel), a thromboxane A2 synthase inhibitor, is one of the most studied drugs which may reduce the risk of neurological impairment and reduce the volume of brain damage. In Japan Ozagrel sodium, a thromboxane synthesis enzyme inhibitor was approved in January 1988 for the improvement of postoperative cerebrovascular contraction and accompanying cerebral ischemia. Thereafter an additional indication for improvement of motility disturbance due to acute cerebral thrombosis was approved in April 1992. USA may have their own guidelines in respect of certain medicines, but the same cannot be applied universally due to racial differences as well as differences in approved therapeutic agents, and disease sub-types between India and other countries. These stroke guidelines approved by the USA therefore, can not necessarily be directly adopted into clinical practice in India.

18.     It is pertinent to note that the drugs Ozagrel (Strozagel) and   Edaravon (Nuravon) were available in the market with the chemist. The trial was in the 4^th phase, which does not require any informed consent of the patient. The only phase which requires informed consent of the patient is 1^st and 2^nd phase. In that phase, the drugs are not available in the market with the chemist for sale.  The mother of the Complainants was suffering from Hypertension (high Blood Pressure), Diabetes Mellitus (Sugar), and severe obesity. She was at risk of cardiac problems and she suffered stroke before admission in the Opposite Party hospital. The kidney injury was due to the consequences of several factors like long standing Diabetes, high BP and Infection. The patient was treated as per the accepted standard in medical protocol. The patient was recovered from renal insufficiency and serum Creatinine became within limits.  Both Ozagrel and Edaravon well known drugs are used for treatment of stroke, and therefore there was no need of prior consent. The Complainants have misconceived them as trial drugs. The Complainants were attributing the causation of heart attack and respiratory failure to injection Ozagrel and Edaravon. In our view, Inj Ozagrel does not cause heart attack, but as an antiplatelet agent, it is considered to be beneficial for the treatment of ischemic heart disease. It acts like Aspirin and Copidogrel anti-platelet agents. Moreover, the drug Ozagrel is approved by DGCI for the treatment of acute bronchial asthma, one of the causes of respiratory failure. In the present case, the patient was suffering not only from hypertension, diabetes mellitus and severe obesity but also from hypothyroidism, which was diagnosed after admission. There was hypoproteinemia and lower respiratory tract infection noted by Dr. Ashok Kumar on 03.03.2012.

19.     The Complainants raised inclusion and exclusion criteria, which are not part of any recommendation or guidelines of any official body or any expert body. These are simply part of research study. Any drug trial study needs  Inclusion criteria — to include the patient for study, and Exclusion criteria — to exclude confounders (confounding factors) to have a homogeneous patient population in roughly the same stage and condition and also to exclude certain patients for ethical reasons — not including if the patient is improving, if the risks are very high etc. By projecting such study as guideline, the Complainants are misleading this Commission. The Office of DGHS has aptly replied that no permission was given for trial in respect of Edarvon. Ozagrel is an extensively used drug for ischemic stroke. Therefore, in our view, there was no malpractice or any violation of rules by the treating doctors.

20.     Let us examine the claim of the Complainants.  It was submitted that the deceased patient was taking “all attention and care" of her autistic grandchild in USA. She was expected to live upto 86 years as per US data i.e. upto another 14 years. In our view, it is surprising about the Complainants for such guess work that the 72 years old lady having multiple comorbidities would take care of autistic child for further 14 years. Thus the Complainants have deliberately attempted to claim an exorbitant compensation without any basis, which was, just, to come under the jurisdiction of this Commission.

21.     Based on the foregoing discussion, we do not find any negligence or any mal practice on the part of the Opposite Parties. The Complaint lacks merit, hence dismissed.

22.     There shall be no Order as to costs.